The invention relates to an assaying system. More particularly, the invention relates to a machine readable assaying system for analyzing a specimen of physiological fluid to detect the presence or absence of particular substances therein. In a preferred embodiment, the machine readable assaying system contemplates the utilization of machine readable bar-code patterns imprinted upon a test card which change form in response to a physical, chemical or biological reaction. The test result which is encoded within the bar-code indicia imprinted upon the test card is read by an appropriate decoding apparatus (i.e. a bar-code reader/scanner), and the decoded results are stored in a memory unit and transmitted, if desired, to a distinct location. A test administrator merely scans the bar-code. Because the bar-code patterns change form in such a subtle yet varied manner, the administrator or another observer of the test card is unable to discern the results. Accordingly, the privacy interests of the donor are preserved, as well as human interpretation errors, transcription and translation errors.
The increase in drug use over the past several decades has created a sharp need for more effective, expeditious methods of analyzing whether a particular individual is a user of certain illegal substances. Both private industry employers as well as governmental employers often need to determine whether an individual has drug residue present in his or her biological system, and hence determine whether such an individual is a drug user or drug abuser and thus an unqualified employee.
Typically, the status of an individual as a drug user or abuser is determined by analysis of the individual""s physiological fluids, namely urine. A specimen of urine is collected, and a highly sensitive screening test is first performed, usually at a centralized laboratory. If specimen samples screen positive at the central laboratory, then a more sensitive and controlled confirmation analysis must be performed.
In addition to being an extremely costly process, the above mentioned procedure also involves great time delays to employers desirous of obtaining new qualified employees. Upon collection of the urine sample, the employer must wait to receive test results from the central laboratory before hiring any potential employees. Furthermore, the massive amount of handling and transfer of the sample of urine from the initial collection site to the central laboratory.
To combat the above mentioned timeliness problem which faces many employees in awaiting results from the central laboratory, various xe2x80x9con-sitexe2x80x9d or xe2x80x9chand-heldxe2x80x9d assaying devices have been developed. A major problem inherent in these xe2x80x9con-sitexe2x80x9d testing devices is that the privacy concerns of the potential employee being tested are not adequately addressed. Since all of the on-site testing devices available heretofore attempt merely to identify drugs present (i.e. simply to indicate which specimens do indeed possess the prohibited substance/drug), the anonymity of a presumptive positive donor is impossible to conceal. Due to such lack of anonymity, many employers (governmental in particular) will not employ such an assaying system as it does not comply with federally mandated regulations regarding privacy and civil liberties during drug-employment testing. A more anonymous, reliable and expeditious assaying system is needed, wherein negative results can be obtained quickly without compromising the privacy concerns of the tested individual. The results are not xe2x80x9chuman readablexe2x80x9d and thus are not subject to interpretation.
It is an object of the invention to produce an assaying system for analyzing a specimen of body fluid to detect the absence of particular substances therein.
It is another object of the invention to provide an assaying system which provides more anonymous, reliable and expeditious results than those assaying systems presently found in the art, wherein said results can be obtained quickly without compromising the privacy concerns of the tested donor individual.
It is a further object of the invention to provide an on-site, portable assaying system which allows the results of said assay to be determined and utilized almost immediately by an employer, without jeopardizing the privacy rights of the individual being tested.
It is a still further object of the invention to provide an assaying system which allows the results of said assay to be encoded in a machine readable format (such as bar-coding) such that said encoded results are visually undetectable and must be de-coded by appropriate apparatus. Accordingly, the administrator of the assay lacks access to the test results.
It is yet another object of the invention to provide an assaying system which possesses a memory unit to store resultant decoded assay data, and communication means for transmitting said decoded data to a distinct location (such as a central laboratory/processing office). Upon receiving the assay data, the central laboratory/processing office could then electronically, telephonically or manually (via a delivered hard copy) communicate a responsive xe2x80x9cnegative test certificatexe2x80x9d to the employer for those individuals testing negative (indicating that these individuals are candidates for immediate employment). A sample specimen of physiological fluid from only those individuals who tested positive would then be requested by the central laboratory for standard xe2x80x9cconfirmationxe2x80x9d testing.
It is yet another object of the invention to provide an assaying system such as that discussed above which possesses means capable of detecting adulteration of the specimen.